Reaction Mass of Valencene and Aristolochene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Seven male and three female New Zealand White rabbits with initial body weights between 2.0 and 2.5 kg.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Treated on clipped, intact or abraded abdominal skin under occluded patches

Duration of exposure:

24-hours of contact

Doses:

5,000 mg/kg bw

No. of animals per sex per dose:

Seven male
Three female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: dermal reactions were scored on days 1, 7, and 14 and observations for mortality and/or systemic effects were made daily
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Mortality:

No deaths in the 10 animals tested

Clinical signs:

other: Clinical signs observed during the study included lethargy, diarrhea and few feces.

Gross pathology:

Necropsy revealed crusted or scaly skin in three animals at the treatment site.

Data source

Reference

Reference Type:

publication

Title:

Erratum to Monograph ''Valencene''

Author:

Letizia, C.S., Cocchiara, J., Wellington, G.A., Funk, C. and Api, A.M.

Year:

2001

Bibliographic source:

[Food and Chemical Toxicology 38 Supplement 3 (2000) S235-S236]. Food and Chemical Toxicology, 7(39), p.757.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

[1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene

EC Number:

225-047-6

EC Name:

[1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene

Cas Number:

4630-07-3

Molecular formula:

C15H24

IUPAC Name:

3-isopropenyl-4a,5-dimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalene

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Seven male and three female New Zealand White rabbits with initial body weights between 2.0 and 2.5 kg.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

clipped, intact or abraded abdominal skin

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

5,000 mg/kg bw

Duration of treatment / exposure:

24-hour contact

Observation period:

Dermal reactions were scored on days 1, 7, and 14

Number of animals:

Seven male
Three female

Details on study design:

Seven male and three female New Zealand White rabbits with initial body weights between 2.0 and 2.5 kg were treated on clipped, intact or abraded abdominal skin under occluded patches for 24-hours on contact.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

2.5

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.8

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1.4

Max. score:

2

Reversibility:

fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met